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240 mL Water Drink Study

3. juli 2013 opdateret af: University of Nottingham

MRI Quantification of Gastric and Small Bowel Liquid Volumes Before and After Ingestion of the Standard Oral Solid Delivery 240 mL Water Drink

The GI MRI Research group at the University of Nottingham has been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract. The investigators now want to characterise; in collaboration with the College of Pharmacy at the University of Michigan, the fasting volumes of gastric and small bowel liquid and their time courses over 2 hours after drinking the FDA recommended 240 mL of water drink for oral solid dosage forms testing.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Solid oral delivery is the most frequently used route of administration for pharmaceutical drug products. Along with other important physiological parameters, the volume of liquid in the small intestine (SILV) has the potential to greatly influence the rate and extent of drug dissolution and absorption in the GI tract, or "oral bioperformance". Modeled small bowel absorption of a drug can vary by more than five-fold as SILV decreases from 500 to 50 ml. To obtain reasonable predictions of oral bioperformance scientists must design meaningful in vitro dissolution tests and mechanistic drug transport models that capture the range of SILV in humans. However, little is known about liquid volumes in the gut, mostly due to invasiveness of previous techniques. A recent study has drawn great attention to the possibility of the liquid in the small intestine existing in discrete liquid "pockets" hence it would also be desirable to monitor the time courses and volumes of individual water pockets in the small intestine.

Magnetic resonance imaging (MRI) is the ideal tool to carry out serial and non-invasive imaging of gastrointestinal function. MRI is inherently suited to image liquid materials and this ability has been exploited to image liquids in the undisturbed gastrointestinal tract. Gastric emptying measurements have been long established and validated. Small bowel liquid volumes measurements have been recently validated against naso-duodenal infusion. Ultimately, the findings with this study will provide novel insights on the volume and distribution of ingested liquids in the gastrointestinal tract.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Apparently healthy; no medical conditions that might affect the study measurements
  • Male or female
  • Age between 18 and 55 years of age
  • Body mass index (BMI) between 18.5 and 24.9 kg m-2
  • Suitable for MRI scanning (eg absence of metal implants, infusion pumps and pacemakers as assessed by the MRI safety questionnaire

Exclusion Criteria:

  • Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
  • Known gastrointestinal disease
  • Smoking
  • History of alcohol or drug abuse
  • Taking medication that is likely to affect gastrointestinal function
  • Participation in night shift work the week prior to the study day. (Night work is defined as working between midnight and 6 am)
  • Strenuous exercise greater than 10 hours per week
  • Consumption of more than 21 units of alcohol in a typical week

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 240 mL water drink
Volunteers will be asked to drink 240 mL water drink
Andet: Spring water

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time course of small bowel liquid volume after ingesting 240 mL of water
Tidsramme: 0 - 120 mins
Time course for the volume of freely mobile water in the small bowel over 2 hours
0 - 120 mins

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time course of gastric liquid volume after ingesting 240 mL of water
Tidsramme: 0 - 120 mins
Gastric volumes obtained from MRI as a function of time
0 - 120 mins
Number of liquid pockets in the small bowel
Tidsramme: 0 - 120 mins
Assessment of the number of pockets of liquid in the small bowel as seen on the MR images
0 - 120 mins
Volume of liquid pockets in the small bowel
Tidsramme: 0 - 120 mins
The volume of freely mobile liquid in each of the liquid pockets identified on the MR image
0 - 120 mins
Summary information on the location of liquid pockets by quadrant
Tidsramme: 0 - 120 mins
Details on the distribution of the liquid pockets as seen on the MR images
0 - 120 mins

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Nottingham

Samarbejdspartnere

University of Michigan

Efterforskere

  • Ledende efterforsker: Kathryn Murray, PhD, University of Nottingham
  • Ledende efterforsker: Caroline Hoad, PhD, University of Nottingham
  • Ledende efterforsker: Penny Gowland, PhD, University of Nottingham
  • Ledende efterforsker: Susan Pritchard, MSc, University of Nottingham
  • Ledende efterforsker: Martin Garnett, University of Nottingham
  • Ledende efterforsker: Robin Spiller, FRCP, University of Nottingham
  • Ledende efterforsker: Gregory Amidon, University of Michigan
  • Ledende efterforsker: Gordon Amidon, University of Michigan
  • Ledende efterforsker: Deanna Mudie, University of Michigan
  • Studieleder: Luca Marciani, PhD, University of Nottingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2013

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

13. februar 2013

Først indsendt, der opfyldte QC-kriterier

13. februar 2013

Først opslået (Skøn)

15. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. juli 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2013

Sidst verificeret

1. juli 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • A10012013

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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